Systems and methods for making and using paddle lead assemblies for electrical stimulation systems

ABSTRACT

A paddle lead assembly for providing electrical stimulation of patient tissue includes a paddle body. The paddle body includes tour columns of electrodes, each column including at least one electrode. The columns include two outer columns flanking two inner columns. The paddle lead assembly further includes a plurality of lead bodies coupled to the paddle body. At least one terminal is disposed on each of the plurality of lead bodies. A plurality of conductive wires couple each of the electrodes to at least one of the plurality of terminals.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/224,681 filed Sep. 2, 2011 which claims the benefit under 35 U.S.C.§119(e) of U.S. Provisional Patent Application Ser. No. 61/383,634 filedon Sep. 16, 2010, all of which are incorporated herein by reference.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable paddle leads thatinclude electrodes disposed on paddle bodies and one or more lead bodiescoupled to the paddle bodies, as well as methods of making and using theleads, lead bodies, paddle bodies, and electrical stimulation systems.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat chronic pain syndrome and incontinence, with a number of otherapplications under investigation. Functional electrical stimulationsystems have been applied to restore some functionality to paralyzedextremities in spinal cord injury patients.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

SUMMARY

In one embodiment, a paddle lead assembly for providing electricalstimulation of patient tissue includes a paddle body. The paddle bodyincludes four columns of electrodes, each column including at least oneelectrode. The columns include two outer columns flanking two innercolumns. The paddle lead assembly further includes a plurality of leadbodies coupled to the paddle body. At least one terminal is disposed oneach of the plurality of lead bodies. A plurality of conductive wirescouple each of the electrodes to at least one of the plurality ofterminals.

In another embodiment, an electrical stimulating system includes apaddle body. The paddle body includes four columns of electrodes, eachcolumn including at least one electrode. The columns include two outercolumns flanking two inner columns. The paddle lead assembly furtherincludes a plurality of lead bodies coupled to the paddle body. At leastone terminal is disposed on each of the plurality of lead bodies. Aplurality of conductive wires couple each of the electrodes to at leastone of the plurality of terminals. The paddle lead assembly additionallyincludes at least one control module. The at least one control module isconfigured and arranged to electrically couple to each of the pluralityof lead bodies. Each of the at least one control module includes ahousing and an electronic subassembly disposed in the housing. Aconnector is configured and arranged for receiving at least one of theplurality of lead bodies, the connector includes a connector housingdefining at least one port at a distal end of the connector The at leastone port is configured and arranged tor receiving a portion of at leastone of the plurality of lead bodies. At least one connector contact isdisposed in each of the at least one ports defined by the connectorhousing. The at least one connector contact is configured and arrangedto couple to the at least terminal disposed on each of the plurality ofthe lead bodies.

In yet another embodiment, a method for implanting a paddle leadincludes inserting a paddle lead assembly into a patient, the paddlelead assembly including a paddle body. The paddle body includes fourcolumns of electrodes, each column including at least one electrode. Thecolumns include two outer columns flanking two inner columns. The paddlelead assembly further includes a plurality of lead bodies coupled totire paddle body. At least one terminal is disposed on each of theplurality of lead bodies. A plurality of conductive wires couple each ofthe electrodes to at least one of the plurality of terminals. The paddlelead assembly additionally includes at least one extension elementcoupling each of the plurality of lead bodies to the paddle body. Ajunction couples the at least one extension element to each of theplurality of lead bodies. The plurality of conductive wires extend alongthe at least one extension element to the junction. The plurality ofconductive wires are divided up into a plurality of distinct groupingsin the junction. A different one of the groupings of conductive wiresextends along each of the plurality of lead bodies. The plurality oflead bodies couple to the junction such that the plurality of leadbodies are arranged into a single layer in a side-by-side configurationthat comprises at least one inner lead body flanked by two outer leadbodies. Each of the plurality of lead bodies is coupled to at least oneadjacent lead body by at least one weakened region configured andarranged to permit manual separation of the coupled lead bodies. Theweakened region between a first proximal element and an adjacent secondproximal element is separated such that the terminals of the firstproximal element are separated from terminals disposed on the secondproximal element. The terminals of the first proximal element areinserted into a connector electrically coupled to an implantable pulsegenerator.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system, according to the invention;

FIG. 2A is a schematic view of one embodiment of a proximal portion of alead, a connector, and a control module of an electrical stimulationsystem, according to the invention;

FIG. 2B is a schematic view of another embodiment of a proximal portionof a lead, a connector, and a control module of an electricalstimulation system, according to the invention;

FIG. 2C is a schematic view of one embodiment of a proximal portion of alead and a lead extension of an electrical stimulation system, accordingto the invention;

FIG. 3A is a schematic view of one embodiment of a paddle lead assemblyof an electrical stimulation system, according to the invention;

FIG. 3B is a schematic view of a second embodiment of a paddle leadassembly of an electrical stimulation system, according to theinvention;

FIG. 3C is a schematic view of a third embodiment of a paddle leadassembly of an electrical stimulation system, according to theinvention;

FIG. 4A is a schematic transverse cross-sectional view of one embodimentof an extension element of a lead body arrangement of the paddle leadassembly of FIG. 3C, according to the invention;

FIG. 4B is a schematic transverse cross-sectional view of one embodimentof an extension element of a lead body arrangement of the paddle leadassembly of FIG. 3C, according to the invention;

FIG. 4C is a schematic transverse cross-sectional view of one embodimentof an extension element of a lead body arrangement of the paddle leadassembly of FIG. 3C, according to the invention;

FIG. 5A is a schematic transverse cross-sectional view of one embodimentof a multi-layer arrangement of lead bodies disposed in a junction ofthe paddle lead assembly of FIG. 3C, according to the invention;

FIG. 5B is a schematic transverse cross-sectional view of anotherembodiment of a one-layer arrangement of lead bodies disposed in ajunction of the paddle lead assembly of FIG. 3C, according to theinvention;

FIG. 6A is a schematic side view of one embodiment, of proximal ends oflead bodies of a lead body arrangement, the lead bodies coupled togetherby perforated regions, according to the invention;

FIG. 6B is a schematic side view of one embodiment of proximal ends ofthe lead bodies of FIG. 6A, with one of the lead bodies separated fromthe other lead bodies due to separation along a perforated region,according to the invention; and

FIG. 7 is a schematic overview of one embodiment of components of astimulation system, including an electronic subassembly disposed withina control module, according to the invention.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable paddle leads thatinclude electrodes disposed on paddle bodies and one or more lead bodiescoupled to the paddle bodies, as well as methods of making and using theleads, lead bodies, paddle bodies, and electrical stimulation systems.

Suitable implantable electrical stimulation systems include, but are notlimited to, an electrode bad (“lead”) with one or more electrodesdisposed on a distal end of the lead mid one or more terminals disposedon one or more proximal ends of the lead. Leads include, for example,percutaneous leads, paddle leads, and cuff leads. Examples of electricalstimulation systems with leads are found in, for example, U.S. Pat. Nos.6,181,969; 6,516,227; 6,609,029; 6,609,032; and 6,741,892; 7,244,150;7,672,734; 7,761,165; 7,949,395; 7,974,706; and U.S. Patent ApplicationsPublication Nos. 2005/0165465; 2007/0150036; 2007/0219595; and2008/0071320, all of which are incorporated by reference.

FIG. 1 illustrates schematically one embodiment of an electricalstimulation system 100. The electrical stimulation system includes acontrol module (e.g., a stimulator or pulse generator) 102, a paddlebody 104, and at least one lead body 106 coupling the control module 102to the paddle body 104. The paddle body 104 and the one or more lead,bodies 106 form a lead. The paddle body 104 typically includes an arrayof electrodes 134. The control module 102 typically includes anelectronic subassembly 110 and an optional power source 120 disposed ina sealed housing 114. The control module 102 typically includes aconnector 144, 201 (FIGS. 2A and 2B, see also 222 and 250 of FIG. 2C)into which the proximal end of the one or more lead bodies 106 can beplugged to make an electrical connection via conductive contacts on thecontrol module 102 and terminals (e.g., 210 in FIGS. 2A and 2B and 236of FIG. 2C) on each of the one or more lead bodies 106. In addition, oneor more lead extensions 212 (see FIG. 2C) can be disposed between theone or more lead bodies 106 and the control module 102 to extend thedistance between the one or more lead bodies 106 and the control module102.

The electrical stimulation system or components of the electricalstimulation system, including one or more of the lead bodies 106, thepaddle body 104, and the control module 102, are typically implantedinto the body of a patient. The electrical stimulation system can beused for a variety of applications including, but not limited to, spinalcord stimulation, brain stimulation, neural stimulation, musclestimulation, and the like.

The electrodes 134 can be formed using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. The number of electrodes 134 in the array ofelectrodes 134 may vary. For example, there can be two, four, six,eight, ten, twelve, fourteen, sixteen, or more electrodes 134. As willbe recognized, other numbers of electrodes 134 may also be used.

The electrodes of the paddle body 104 or one or more lead bodies 106 aretypically disposed in, or separated by, a non-conductive, biocompatiblematerial including, for example, silicone, polyurethane, and the like orcombinations thereof. The paddle body 104 and one or more lead bodies106 may be formed in the desired shape by any process including, forexample, molding (including injection molding), casting, and the like.Electrodes and connecting wires can be disposed onto or within a paddlebody either prior to or subsequent: to a molding or casting process. Thenon-conductive material typically extends from the distal end of thelead to the proximal end of each of the one or more lead bodies 106. Thenon-conductive, biocompatible material of the paddle body 104 and theone or more lead bodies 106 may be the same or different. The paddlebody 104 and the one or more lead bodies 106 may be a unitary structureor can be formed as two separate structures that are permanently ordetachably coupled together.

Terminals (e.g., 210 in FIG. 2A and 236 of FIG. 2C) are typicallydisposed at the proximal end of the one or more lead bodies 106 forconnection to corresponding conductive contacts (e.g., 214 in FIG. 2Aand 240 of FIG. 2C) in connectors (e.g., 144 in FIGS. 1-2A and 222 and250 of FIG. 2C) disposed on, for example, the control module 102 (or toother devices, such as conductive contacts on a lead extension, anoperating room cable, a splitter, or an adaptor). Conductive wires (notshown) extend from die terminals (e.g., 210 in FIG. 2A and 236 of FIG.2C) to the electrodes 134. Typically, one or more electrodes 134 areelectrically coupled to a terminal (e.g., 210 in FIG. 2A and 236 of FIG.2C). In some embodiments, each terminal (e.g., 210 in FIG. 2A and 236 ofFIG. 2C) is only connected to one electrode 134. The conductive wiresmay be embedded in the non-conductive material of the lead or can bedisposed in one or more lumens (not shown) extending along the lead. Insome embodiments, there is an individual lumen for each conductive wire.In other embodiments, two or more conductive wires may extend through alumen. There may also be one or more lumens (not shown) that open at, ornear, the proximal end of the lead, for example, for insetting a styletrod to facilitate placement of the lead within a body of a patient.Additionally, there may also be one or more lumens (not shown) that openat, or near, the distal end of the lead, for example, for infusion ofdrugs or medication into die site of implantation of the paddle body104. In at least one embodiment, the one or more lumens may be flushedcontinually, or on a regular basis, with saline, epidural, fluid, or thelike. In at least some embodiments, the one or more lumens can bepermanently or removably scalable at the distal end.

In at least some embodiments, leads are coupled to connectors disposedon control modules. FIG. 2A is a schematic perspective view of oneembodiment of the one-port connector 144 disposed on the control module102. FIG. 2B is a schematic perspective view of one embodiment of atwo-port connector 201 disposed on the control, module 102. One or moreleads 208 are shown configured and arranged for insertion to the controlmodule 102. The connector 144 includes a connector housing 202. Theconnector housing 202 defines at least one port 204 into which aproximal end 206 of the one or more leads 208 with terminals 210 can beinserted, as shown by directional arrows 212. The connector housing 202also includes a plurality of conductive contacts 214 within each port204. When the one or more leads 208 are inserted into the port 204, theconductive contacts 214 can be aligned with the terminals 210 on thelead(s) 208 to electrically couple the control module 102 to theelectrodes (134 of FIG. 1) disposed at a distal end of the one or moreleads 208. Examples of connectors in control modules are found in, forexample, U.S. Pat. No. 7,244,150 and U.S. Patent Application PublicationNo. 2008/0071320 A1, which are incorporated by reference.

It will be understood that the control module 102 may have any suitablenumber of ports including, for example, one, two, three, four, five,six, seven, eight, or more ports. It will also be understood that eachof the ports can have any number of conductor contacts 214 disposed inthe port. For example, in at least some embodiments, the control modulehas four ports, with eight conductive contacts 214 disposed in each portto define a 32-channel control module, which may be an implantable pulsegenerator for generating electrical pulses.

In FIG. 2C, a connector 222 is disposed on a lead extension 224. Theconnector 222 is shown disposed at a distal end 226 of the leadextension 224. The connector 222 includes a connector housing 228. Theconnector housing 228 defines at least one port 230 into which aproximal end 232 of a lead 234 with terminals 236 can be inserted, asshown by directional arrow 238. The connector housing 228 also includesa plurality of conductive contacts 240. When the lead 234 is insertedinto the port 230, the conductive contacts 240 disposed in the connectorhousing 228 can be aligned with the terminals 236 on the lead 234 toelectrically couple the lead extension 224 to the electrodes (134 ofFIG. 1) disposed at a distal end (not shown) of the lead 234.

In at least some embodiments, the proximal end of a lead extension issimilarly configured and arranged as a proximal end of a lead. The leadextension 224 may include a plurality of conductive wires (not shown)that electrically couple the conductive contacts 240 to a proximal end248 of the lead extension 224 that is opposite to the distal end 226. Inat least some embodiments, the conductive wires disposed in the leadextension 224 can be electrically coupled to a plurality of terminals(not shown) disposed on the proximal end 248 of the lead extension 224.In at least some embodiments, the proximal end 248 of the lead extension224 is configured and arranged for insertion into a connector disposedin another lead extension. In other embodiments, the proximal end 248 ofthe lead extension 224 is configured and arranged for insertion into aconnector disposed in a control module. As an example, in FIG. 2C theproximal end 248 of the lead extension 224 is inserted into a connector250 disposed in a control module 252.

It may be useful to design a lead with more electrodes than the leadillustrated in FIG. 1. For example, a patient may be experiencing painemanating from an area greater in size than the dimensions of an arrayof electrodes (e.g., 134 of FIG. 1) disposed on the distal end of aconventional paddle lead. It may also be useful to stimulate two or moresites separately situated along the spinal cord.

One way to increase stimulation coverage is to provide a lead withgreater dimensions and either increase the amount of space betweenadjacent electrodes, or increase the size of one or more of theelectrodes. When the amount of space between adjacent electrodes isincreased or the size of one or more of the electrodes in increased,however, linear electrode density may decrease to a sub-therapeuticlevel.

Another way to increase stimulation coverage is to provide a lead withthe same or larger dimensions and increase the number of electrodes onthe lead. A lead with additional electrodes, however, may also employ anincreased number of conductive wires to electrically couple theelectrodes to one or more pulse generators.

Regardless of how many conductive wires are disposed, on a paddle lead,the paddle lead is typically configured and arranged to couple to one ormore connectors (e.g., on a control module, a lead extension, or thelike). It may, therefore, be an advantage to form, leads to becompatible with conventional connectors. At least some conventionalconnectors include either one port or two ports that are each configuredand arranged with eight conductive contacts to receive eight conductivewires (see e.g., 144 of FIG. 2A and 201 of FIG. 2B). Thus, for example,when a paddle lead includes sixteen electrodes, the conductive wireselectrically coupled to the electrodes may be divided into two leadbodies, with eight conductive wires disposed in each lead body. Wheneight of the sixteen conductive wires are disposed, in each lead body,then each of the lead bodies can be input into a different port of atwo-port connector of for example, a control module or a lead extension.

A paddle lead can include any number of electrodes including, forexample, one, two, three, four, five, six, seven, eight, nine, ten,eleven, twelve, thirteen, fourteen, fifteen, sixteen, eighteen, twenty,twenty-two, twenty-lour, twenty-six, twenty-eight, thirty, thirty-two,thirty-four, thirty-six, thirty-eight, forty, forty-two, forty-four,forty-six, forty-eight, fifty, fifty-two, fifty-four, fifty-six,fifty-eight, sixty-sixty-two, sixty-four, or more electrodes. It will beunderstood that other numbers of electrodes may be used, instead, it maybe an advantage to form leads having numbers of electrodes that aremultiples of eight in order to couple to each conductive contact of aconventional one-port connector having eight conductive contacts. It mayalso be an advantage to form leads having numbers of electrodes that aremultiples of sixteen in order to couple to each contact of aconventional two-port connector having sixteen conductive contacts.

In at least some embodiments, the electrodes disposed on the paddle leadare arranged into columns. The electrodes can be arranged into anynumber of columns including, for example, four, live, six, seven, eight,or more columns. In at least some embodiments, each of the lour columnsincludes eight electrodes. It will be understood that other numbers ofelectrodes, either fewer or greater, may be disposed in each column. Forexample, at least one of the columns may include one, two, three, four,five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen,fifteen, sixteen, seventeen, eighteen, nineteen, twenty, or moreelectrodes.

When a lead includes a plurality of lead bodies, it may be an advantageto form the lead such that each column of electrodes correlates with adifferent lead body (and, in turn, with terminals disposed on those leadbodies) to improve control of stimulation. For example, for afour-column paddle lead with four lead bodies, it may be an advantagefor each of the conductive wires coupled to the electrodes of a firstcolumn to be disposed in a first lead body and each of the conductivewires coupled to the electrodes of a second column to be disposed in asecond lead body, and so on. As another example, for a four-columnpaddle lead with four lead bodies, it may be an advantage for each ofthe conductive wires coupled to the electrodes of outer columns to bedisposed in corresponding outer lead bodies, and each of the conductivewires coupled to electrodes of inner columns to be disposed incorresponding inner lead bodies.

It may further be an advantage to correlate individual electrodes of agiven column of electrodes with individual terminals disposed along agiven lead body. For example, it may be an advantage for conductivewires to couple a proximal-most electrode of a given column ofelectrodes to a proximal-most terminal disposed along a given lead body,and to couple a distal-most electrode of the given column of electrodesto a distal-most terminal disposed along the given lead body. It mayadditionally be an advantage to, likewise, consecutively couple anyintervening electrodes of the given column of electrodes to anyintervening terminals disposed along the given lead body. Alternatively,it may be an advantage for conductive wires to couple a proximal-mostelectrode of a given column of electrodes to a distal-most terminaldisposed on a given lead body, and to couple a distal-most electrode ofthe given column of electrodes to a proximal-most terminal disposed inthe given lead body.

The paddle lead can be configured and arranged for insertion into one ormore connectors in many different ways. In at least some embodiments,conductive wires extending from electrodes disposed, on the paddle bodycan be arranged into a plurality of distinct groupings, and eachgrouping disposed in a different one of a plurality of lead bodies. Inat least some embodiments, each of the lead bodies is configured andarranged for direct insertion into the one or more connectors. In atleast some embodiments, each of the lead bodies is configured andarranged for insertion into a splitter which, in turn, is configured andarranged for insertion Into the one or more connectors. In at least someembodiments, conductive wires extend, from the paddle body to anextension element that, in turn, is coupled, to the lead bodies.

FIG. 3A is a schematic view of one embodiment of an electricalstimulation system 300. The electrical stimulation system 300 includes apaddle lead assembly 302. The paddle lead assembly 302 includes a paddlebody 304 and lead bodies 306. An array of electrodes 308 is disposed onthe paddle body 304. An array of terminals 310 is disposed on each ofthe lead bodies 306. The electrical stimulation system 300 also includesone or more control modules 312 and one or more connectors 314 forcoupling the lead bodies 306 to the control module(s) 312. The terminals310 are insertable into the one or more connectors 314 such thatconductive wires within the lead bodies 306 electrically couple toconductive contacts disposed within one or more ports of the one or moreconnectors 314.

One or more conductive wires electrically couple the electrodes 308 tothe terminals 310. At least a portion of the conductive wires extendwithin the lead bodies 306. In at least some embodiments, each electrode308 is coupled to a single different corresponding terminal 310 on oneof the lead bodies 306 via a single conductive wire. In at least someembodiments, at least one conductive wire extends along each of the leadbodies 306.

In at least some embodiments, the electrodes 308 are arranged intocolumns 316. In at least some embodiments, each different column 316 ofelectrodes is electrically coupled to terminals disposed on a differentone of the lead bodies 306. In at least some embodiments, the paddlebody 304 includes four columns 316 of electrodes. In at least someembodiments, each column 316 includes eight electrodes. In at least someembodiments, each of the lead bodies 306 axe the same length. In atleast some embodiments, at least one of the lead bodies 306 has a lengththat is different from at least one other of the lead bodies 306. In atleast some embodiments, each of the lead bodies 306 has a differentlength.

When multiple lead bodies are inserted into a patient, it may bedifficult for a medical practitioner to identify which proximal end ofwhich lead body corresponds to which electrode(s). Accordingly, it maybe an advantage to provide one or more lead body identificationarrangements to facilitate electrode identification. In at least someembodiments, the one or more lead body identification arrangementsprovide a distinct (e.g., visually, texturally, or the like orcombinations thereof) component to one or more of the lead bodies todistinguish one or more of the lead bodies from one or more of theremaining lead bodies. For example, the lead bodies 306 can be formedwith different lengths to distinguish (e.g., visually distinguish) eachindividual lead body 306 from the other lead bodies 306, therebyfacilitating identification of which lead bodies include conductivewires coupled to which electrodes. These considerations and arrangementsalso apply equally to each of the below-described embodiments of theelectrical stimulation system.

It will be understood that other lead body identification arrangementsmay be used in addition to, or in lieu of, the above-mentionedarrangement to facilitate electrode identification. For example, in atleast some embodiments, one or more distinct (e.g., visually,texturally, or the like or combinations thereof) markers (e.g., ablatedregions, insulated regions, colored regions, rings, bands, or the likeor combinations thereof) can be disposed in or on the proximal end ofone or more of the lead bodies 306 to distinguish between the lead,bodies 306 (e.g., one ring, two rings, three rings, and four rings toindicate electrode column 1, 2, 3, and 4, respectively, or the like).

Any number of lead bodies 306 can be disposed on the paddle leadassembly 302 including, for example, two, three, four, five, six, seven,eight, nine, ten, or more lead, bodies 306. In at least someembodiments, the number of lead bodies 306 is equal to the number ofcolumns 316 of electrodes.

Turning now to FIG. 3B, sometimes a lead body is incompatible with aconnector. For example, a lead body may include a number of terminalsthat exceeds a number of conductor contacts disposed in a connector. Inat least some embodiments, a paddle lead assembly may include one ormore lead splitters that receive lead bodies and split the conductivewires of the received lead bodies into two or more groupings disposed insplitter bodies that, are compatible with, for example, conventionalconnectors.

FIG. 3B is a schematic view of a second embodiment of an electricalstimulation system 330. The electrical stimulation system 330 includes apaddle lead assembly 332. The paddle lead assembly 332 includes a paddlebody 334 and lead bodies 336. An array of electrodes 338 is disposed onthe paddle body 334. An array of terminals 340 is disposed, on each ofthe lead bodies 336. The electrical stimulation system 330 also includeslead splitters 342. The lead splitters 342 include connectors 344 andsplitter lead bodies 346. Splitter terminal arrays 348 are disposed onthe splitter lead bodies 346. The electrical stimulation system 330 alsoincludes the one or more control modules 312 and the one or moreconnectors 314 for coupling the splitter lead bodies 346 to the controlmodule(s) 312.

Conductive wires (not shown) extending within the lead splitters 342electrically couple connector contacts within the splitter connectors344 to terminals of the splitter terminal arrays 348. The splitterconductive wires are split into multiple groupings of conductive wires.Each grouping of conductive wires extends within a different splitterlead body 346. For example, in at least some embodiments, the leadbodies 336 each have sixteen terminals 340 and the splitter terminalarrays 348 each have eight terminals. Thus, in at least someembodiments, a thirty-two electrode paddle lead 332 may be coupled totwo lead bodies 336 each having sixteen terminals 340, and each of twolead splitters 342 may receive one of the sixteen-terminal lead bodies336 and couple the sixteen terminals 340 of the received lead body 336to two splitter terminal arrays 348 each having eight terminals and eachconfigured and arranged for insertion into the one or more connectors314 such that conductive wires within the splitter lead bodies 346electrically couple to conductive contacts disposed within one or moreports of the one or more connectors 314.

FIG. 3B shows the lead splitter 342 that includes two splitter leadbodies 346. It will be understood that the lead splitter 342 may includeany number of splitter lead bodies 346 including, for example, three,four, five, six, seven, eight, nine, ten, or more splitter lead bodies346. Splitter terminals 348 may be disposed on all, or a portion, of thesplitter lead bodies 346.

In at least some embodiments, at least one of the splitter lead bodies346 has a length that is different from at least one other of thesplitter lead bodies 346. As discussed above, when multiple lead bodiesand lead splitters are inserted into a patient, it may be difficult fora medical practitioner to identify which proximal end of which splitterbody corresponds to which electrode(s). Thus, it may be an advantage toform the splitter lead bodies 346 with, different lengths to distinguisheach splitter lead body 346 from the other splitter lead bodies 346,thereby facilitating identification, of which splitter lead body 346includes conductive wires coupled to which electrodes. It may also be anadvantage to incorporate one or more visually distinct markers on one ormore of the splitter lead bodies 346, as discussed above with referenceto the paddle lead assembly 302 and shown in FIG. 3A.

Turning now to FIG. 3C, in at least some embodiments the lead includes alead body arrangement 376. The lead body arrangement 376 includes anextension element 380 and a plurality of lead bodies 382 disposedproximally to the extension element 380. In at least some embodiments,the extension element 380 is coupled to die lead bodies 382 via one ormore junctions 384.

Conductive wires extending within the extension element are divided atthe junction into multiple distinct groupings of conductive wires. Eachdistinct grouping of conductive wires extends within a differentproximal element. At least one of the lead bodies is configured andarranged to couple to a connector such that conductive wires within thelead body electrically couple to connector contacts disposed within oneor more ports of the connector.

FIG. 3C is a schematic view of a third embodiment of an electricalstimulation system 370. The electrical stimulation system 370 includes apaddle lead assembly 372, the paddle lead assembly 372 includes a paddlebody 374 and a lead body arrangement 376. An array of electrodes 378 isdisposed on the paddle body 374. The lead body arrangement 376 includesan extension element 380 coupled to the paddle body 374, a plurality oflead bodies 382, and a junction 384 coupling the extension element 380to the plurality of lead bodies 382. An array of terminals 386 isdisposed on at least one of the plurality of lead bodies 382. Theelectrical stimulation system 370 also includes the one or more controlmodules 312 and the one or more connectors 314 for coupling the proximallead bodies 382 to the control module(s) 312.

In at least some embodiments, the extension element 308 has a lengththat is substantially greater than a length of each of the lead bodies382. In at least some embodiments, at least one of the lead bodies 382has a length that is different than at least one other of the leadbodies 382. When multiple lead bodies and junctions are inserted into apatient, it may be difficult for a medical practitioner to identifywhich proximal end of which lead body corresponds to which electrode(s).Thus, it may be an advantage to form the lead bodies 382 with differentlengths to distinguish each of the lead bodies 382 from one another,thereby facilitating identification of which lead body 382 includesconductive wires coupled to which electrodes.

It may be an advantage to use a paddle lead assembly having a singleextension element extending from the paddle body 374 because using asingle extension element may reduce patient discomfort during insertionor during the implantation period of the electrical stimulation system370. When multiple lead bodies are inserted into a patient such thateach of the lead bodies extends the entire distance between the paddlebody and the control module, multiple tunnels may be bored throughpatient tissue. Each tunnel may cause patient discomfort or lead topotential complications during implantation. Additionally, in order tomaintain precise positioning of paddle bodies during operation, somelead bodies may be anchored to patient tissue. Each anchoring may alsocause patient discomfort or lead to potential complications duringimplantation. It may, therefore, be an advantage to only anchor a singleextension element to patient tissue in proximity to the paddle bodyinstead of anchoring a plurality of lead bodies.

In at least some embodiments, the transverse profile of the extensionelement may be reduced to further reduce patient discomfort. In at leastsome embodiments, the extension, element is formed from a singleextrusion of one or more polymers (e.g., ethylene tetrafluoroethylene,perfluoroalkoxy, or the like) coated with one or more layers ofbiocompatible, biostable insulating material (e.g., polyurethane,silicone, or the like).

Conductive wires can be disposed in the extension element 380 in anyconfiguration. It may be an advantage to extend conductive wires alongthe extension element 380 arranged into distinct (by sight, by touch, orthe like) groupings that correspond to each of the plurality of leadbodies 382. In at least some embodiments, one or more dividers mayextend along all, or a portion, of the extension element 380 to separateone or more of the groupings from one another. FIG. 4A is a schematictransverse cross-sectional view of one embodiment of an arrangement ofdividers 402 disposed along the extension element 380. FIG. 4B is aschematic transverse cross-sectional view of a second embodiment of anarrangement of dividers 402 disposed along the extension element 380.FIG. 4C is a schematic transverse cross-sectional view of a thirdembodiment of an arrangement of dividers 402 disposed along theextension element 380.

The transverse profile of the extension element 380 can be any geometricor non-geometric shape including, for example, round, oval, rectangular,rounded rectangular, or the like. In preferred embodiments, thetransverse profile of the extension element is formed so as to reducepatient discomfort. In at least some embodiments, the extension element380 does not receive a stylet. In at least some embodiments, theextension element 380 does not couple directly to the one or moreconnectors 314.

In at least some embodiments, the plurality of lead bodies 382 eachcouple to the junction 384 such that the lead bodies 382 are stacked,into two or more layers. FIG. 5A is a schematic transversecross-sectional view of one embodiment of the lead bodies 382 extendingwithin the junction 384. The lead bodies 382 are arranged into twolayers 502 and 504. It will be understood that the lead bodies 382 canbe arranged into any number of layers, and each layer may include anynumber of lead bodies 382.

In at least some embodiments, the lead bodies 382 couple to the junction384 such that the lead bodies 382 are arranged into a single layer. FIG.5B is a schematic transverse cross-sectional view of one embodiment ofthe lead bodies 382 extending within the junction 384. The lead bodies382 are arranged into a single layer 506. It may be an advantage tocouple the lead bodies 382 to the junction 384 in a single layer becausea single layer of lead bodies 382 may produce less patient discomfortthan multiple layers, it may also be an advantage to couple the leadbodies 382 to the junction 384 in a single layer because the arrangementof the lead bodies 382 may be configured in a manner that is similar tothe arrangement of the electrodes 378, thereby facilitatingidentification of which lead body includes terminals coupled to whichelectrodes, or columns of electrodes.

Turning now to FIGS. 6A and 6B, in at least some embodiments the leadbodies 382 are at least partially coupled together along at least aportion of a longitudinal axis of the lead bodies 382. In at least someembodiments, the lead bodies 382 are coupled together such, that one ormore perforated regions (e.g., weakened regions, or the like) are formedalong at least a portion of the coupled portions. In at least someembodiments, one or more of the lead bodies 382 can be separated fromthe other lead bodies 382 along one or more of the perforated regionsand inserted into a connector.

FIG. 6A is a schematic side view of one embodiment of proximal ends ofthe lead bodies 382. The lead bodies 382 are arranged in a single layersuch that the lead bodies 382 are in a side-by-side configuration. Thelead bodies 382 are coupled together by one or more perforated regions,such as perforated region 602 extending along a longitudinal axis, shownin FIG. 6A as an arrow 604. In at least some embodiments, one or more ofthe perforated regions may be separated to partially detach one or moreof the lead bodies 382 from one or more other of the lead bodies 382.

FIG. 6B is a schematic side view of one embodiment of proximal ends ofthe lead bodies 382. One of the perforated regions 602 has beenseparated along a proximal-most portion of the perforated region topartially separate one of the lead bodies 382 from the other lead bodies382. In at least some embodiments, the separated lead body 382 can beinserted into a connector (e.g. of a control module, a lead extension,or the like). In at least some embodiments, the one or more perforatedregions 602 can be separated by a medical practitioner duringimplantation of the electrical stimulation system 370. In at least someembodiments, the one or more perforated regions 602 can be separatedafter the paddle lead assembly 372 is inserted into a patient.

FIG. 7 is a schematic overview of one embodiment of components of anelectrical stimulation system 700 including an electronic subassembly710 disposed within a control module. It will be understood that theelectrical stimulation system can include more, fewer, or differentcomponents and can have a variety of different configurations includingthose configurations disclosed in the stimulator references citedherein.

Some of the components (for example, power source 712, antenna 718,receiver 702, and processor 704) of the electrical stimulation systemcan be positioned on one or more circuit boards or similar carrierswithin a sealed housing of an implantable pulse generator, if desired.Any power source 712 can be used including, for example, a battery suchas a primary battery or a rechargeable battery. Examples of other powersources include super capacitors, nuclear or atomic batteries,mechanical resonators, infrared collectors, thermally-powered energysources, flexural powered energy sources, bioenergy power sources, fuelcells, bioelectric cells, osmotic pressure pumps, and the like includingthe power sources described in U.S. Patent Application Publication No.2004/0059392, incorporated herein by reference.

As another alternative, power can be supplied by an external powersource through inductive coupling via the optional antenna 718 or asecondary antenna. The external power source can be in a device that ismounted on the skin of the user or in a unit that is provided near theuser on a permanent or periodic basis.

If the power source 712 is a rechargeable battery, the battery may berecharged using the optional antenna 718, if desired. Power can beprovided to the battery for recharging by inductively coupling thebattery through the antenna to a recharging unit 716 external to theuser. Examples of such arrangements can be found in the referencesidentified above.

In one embodiment, electrical current is emitted by the electrodes 134on the paddle or lead body to stimulate nerve fibers, muscle fibers, orother body tissues near the electrical stimulation system. A processor704 is generally included to control the liming and electricalcharacteristics of the electrical stimulation system. For example, theprocessor 704 can, if desired, control one or more of the timing,frequency, strength, duration, and waveform of the pulses. In addition,the processor 704 can select which electrodes can be used to providestimulation, if desired. In some embodiments, the processor 704 mayselect winch electrode(s) are cathodes and which electrode(s) areanodes. In some embodiments, the processor 704 may be used to identifywhich electrodes provide the most useful stimulation of the desiredtissue.

Any processor can be used and can be as simple as an electronic devicethat, for example, produces pulses at a regular interval or theprocessor can be capable of receiving and interpreting instructions froman external programming unit 708 that, for example, allows modificationof pulse characteristics. In the illustrated embodiment, the processor704 is coupled to a receiver 702 which, in turn, is coupled to theoptional antenna 718. This allows the processor 704 to receiveinstructions from an external source to, for example, direct the pulsecharacteristics and the selection of electrodes, if desired.

In one embodiment, the antenna 718 is capable of receiving signals(e.g., RF signals) from an external telemetry unit 706 which isprogrammed by a programming unit 708, the programming unit 708 can beexternal to, or part of, the telemetry runt 706. The telemetry unit 706can be a device that is worn on the skin of the user or can be carriedby the user and can have a form similar to a pager, cellular phone, orremote control, if desired. As another alternative, the telemetry unit706 may not be worn or carried by the user but may only be available ata home station or at a clinician's office, the programming unit 708 canbe any unit that can provide information to the telemetry unit 706 fortransmission to the electrical stimulation system 700. The programmingunit 1508 can be part of the telemetry unit 706 or can provide signalsor information to the telemetry unit 706 via a wireless or wiredconnection. One example of a suitable programming unit is a computeroperated by the user or clinician to send signals to the telemetry unit706.

The signals sent to the processor 704 via the antenna 718 and receiver702 can be used to modify or otherwise direct the operation of theelectrical stimulation system. For example, the signals may be used tomodify the pulses of the electrical stimulation system such as modifyingone or more of pulse duration, pulse frequency, pulse waveform, andpulse strength. The signals may also direct the electrical stimulationsystem 700 to cease operation, to start operation, to start charging thebattery, or to stop charging the battery. In other embodiments, thestimulation system dues not include an antenna 718 or receiver 702 andthe processor 704 operates as programmed.

Optionally, the electrical stimulation system 700 may include atransmitter (not shown) coupled to the processor 704 and the antenna 718for transmitting signals back to the telemetry unit 706 or another unitcapable of receiving the signals. For example, the electricalstimulation system 700 may transmit signals indicating whether theelectrical stimulation system 700 is operating properly or not orindicating when the battery needs to be charged or the level of chargeremaining in the battery. The processor 704 may also be capable oftransmitting information about the pulse characteristics so that a useror clinician can determine or verify the characteristics.

The above specification, examples and data provide a description of themanufacture and use of the composition of the invention. Since manyembodiments of the invention can be made without departing from thespirit and scope of the invention, the invention also resides in theclaims hereinafter appended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A paddle lead assembly for providing electricalstimulation of patient tissue, the lead comprising: a paddle body havinga longitudinal length; a plurality of electrodes disposed along thepaddle body and arranged into four columns that each comprise at leasttwo electrodes and that each extend along the longitudinal length of thepaddle body, wherein the four columns of electrodes includes two outercolumns flanking two inner columns; an extension element having alongitudinal length, a first end, and an opposing second end, the firstend of the extension element coupled to the paddle body; a plurality oflead bodies coupled to the second end of the extension element, theplurality of lead bodies comprising a first lead body and a second leadbody; a plurality of terminals arranged into a plurality of terminalarrays disposed along the plurality of lead bodies, the plurality ofterminal arrays comprising a first terminal array disposed along thefirst lead body and a second terminal array disposed along the secondlead body; and a plurality of conductive wires extending along thelongitudinal length of the extension element and coupling the pluralityof electrodes to the plurality of terminals, the plurality of conductivewires divided up into a plurality of distinct wire groupings with eachof the plurality of distinct wire groupings having different conductivewires of the plurality of conductive wires from the remaining distinctwire groupings, the plurality of distinct groupings comprising a firstdistinct wire grouping and a second distinct wire grouping, wherein thefirst distinct grouping is coupled to the first terminal array and thesecond distinct grouping is coupled to the second terminal array.
 2. Thepaddle lead assembly of claim 1, wherein each of the four columns ofelectrodes comprises eight electrodes.
 3. The paddle lead assembly ofclaim 1, wherein the number of lead bodies is equal to the number ofcolumns of electrodes.
 4. The paddle lead assembly of claim 1, whereinthe longitudinal length of the extension element is substantiallygreater than lengths of each of the plurality of lead bodies.
 5. Thepaddle lead assembly of claim 1, wherein at least one of the pluralityof lead bodies has a length that is different from a length of at leastone other of the plurality of lead bodies.
 6. The paddle lead assemblyof claim 1, wherein each lead body of the plurality of lead bodies has adifferent length from the remaining lead bodies of the plurality of leadbodies.
 7. The paddle lead assembly of claim 1, wherein each of theplurality of lead bodies is coupled to at least one adjacent lead bodyby at least one weakened region configured and arranged to permit manualseparation of the coupled lead bodies.
 8. The paddle lead assembly ofclaim 1, wherein a number of distinct wire groupings is equal to anumber of columns of electrodes.
 9. The paddle lead assembly of claim 1,wherein each terminal array of the plurality of terminal arrays iscoupled to a different column of electrodes than the remaining terminalarrays.
 10. The paddle lead assembly of claim 1, wherein each distinctwire grouping extending along the extension element is separated fromthe remaining distinct wire groupings by at least one divider thatextends along at least a portion of the longitudinal length of theextension element and that divides at least a portion of the extensionelement into at least two distinct co-axial regions.
 11. The paddle leadassembly of claim 10, wherein the at least two distinct co-axial regionscomprise an inner region and an outer region that is concentric to theinner region along the longitudinal length of the extension element. 12.The paddle lead assembly of claim 1, further comprising at least onelead splitter.
 13. The paddle lead assembly of claim 12, wherein the atleast one lead splitter comprises a splitter connector and at least twosplitter lead bodies, and wherein the splitter connector is configuredand arranged to receive at least one of the plurality of lead bodies.14. The paddle lead assembly of claim 1, further comprising a junctiondisposed at the second end of the at least one extension element, thejunction coupling the extension element to each of the plurality of leadbodies.
 15. The paddle lead assembly of claim 14, wherein the pluralityof lead bodies comprises two lead bodies, and wherein the two leadbodies are coupled to the junction such that the plurality of leadbodies are arranged in a side-by-side configuration.
 16. The paddle leadassembly of claim 14, wherein the plurality of lead bodies comprises atleast three lead bodies, and wherein the plurality of lead bodies arecoupled to the junction such that the plurality of lead bodies arearranged into a single layer in a side-by-side configuration thatcomprises at least one inner lead body flanked by two outer lead bodies.17. The paddle lead assembly of claim 16, wherein the electrodes of eachof the outer columns are electrically coupled to the terminal arraysdisposed along the two outer lead bodies and the electrodes of each ofthe inner columns are electrically coupled to the at least one terminalarray disposed along the at least one inner lead body.
 18. The paddlelead assembly of claim 14, wherein the plurality of lead bodiescomprises four lead bodies, and wherein the plurality of lead bodies arecoupled to the junction such that the plurality of lead bodies arestacked into a plurality of layers, each layer comprising at least twolead bodies arranged in a side-by-side configuration.
 19. An electricalstimulating system comprising: the paddle lead assembly of claim 1; atleast one control module configured and arranged to electrically coupleto each of the plurality of lead bodies, each of the at least onecontrol modules comprising a housing, and an electronic subassemblydisposed in the housing; and a connector configured and arranged forreceiving the plurality of lead bodies, the connector comprising aconnector housing defining a plurality of ports configured and arrangedfor receiving a portion of each of the plurality of lead bodies, and aplurality of connector contacts disposed in each of the plurality ofports defined by the connector housing, the plurality of connectorcontacts configured and arranged to couple to the plurality of terminalarrays disposed along the plurality of the lead bodies.
 20. Theelectrical stimulating system of claim 19, further comprising at leastone lead extension coupling each of the plurality of lead bodies to theat least one control module.